Petroleum Jelly
FDA Label NDC 53329-068

12 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Petroleum (NDC 53329-068). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Gram)

White petrolatum, USP (100% w/w)

Purpose

Skin Protectant

Uses

  • temporarily protects minor: cuts, scrapes and burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

  • For external use only

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed.

Other Information

  • protect from freezing, avoid excessive heat
  • Use only if packaging is intact.
  • preserve inb well-closed containers

* Please review the disclaimer below.